Effect of Long Term Cocoa Flavanol Intake on Blood Pressure and Platelet Function in Healthy Adults, Part 1
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- University of California, Davis
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Change in blood pressure
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Flavanols are plant-derived compounds commonly present in the human diet. Examples of flavanol-containing foods and beverages are apples, chocolate, tea, wine, berries, pomegranate and nuts. The consumption of flavanol-containing foods and beverages has been associated with improvements in cardiovascular health. In this study, the investigators hope to learn more about the effects of the consumption of increasing amounts of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans. This study was followed by a second study that aimed at investigating the effects of long term consumptions of cocoa flavanols on blood pressure, platelet function and other metabolic parameters in healthy humans.
Investigators
Eligibility Criteria
Inclusion Criteria
- •30-55 years old
- •A normal blood chemistry and liver function
- •BMI \< 30 kg/m2
- •previously consumed cocoa and peanut products, with no adverse reactions
Exclusion Criteria
- •A history of cardiovascular disease, stroke, hypertension, renal, hepatic, or thyroid disease, GI tract disorders, previous GI surgery, metabolic syndrome, diabetes, taking cholesterol-lowering medication, hormone replacement therapy, antioxidant supplements, on aspirin therapy or taking anticoagulants, or on a medically prescribed diet.
- •Allergies to nuts, cocoa and chocolate products
- •Vegetarian, Vegan, food faddists, individuals using non-traditional diets, on a weight loss diet or using herbal dietary supplements
Outcomes
Primary Outcomes
Change in blood pressure
Time Frame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Blood pressure will be measured using standard techniques.
Change in platelet function
Time Frame: Baseline and 14, 28, 42 and 56 days after intervention
Platelet function will be determined using the PFA-100® analyzer (Dade Behring International, Miami, FL) with collagen-epinephrine (CEPI)- and collagen-ADP (CADP) stimulation.
Change in metabolic parameters in blood
Time Frame: Baseline (day 0) and 14, 28, 42 and 56 days after intervention
Metabolic parameters determined in blood included: comprehensive metabolic panel, liver panel and cell blood counting.
Secondary Outcomes
- Change in plasma concentration of cocoa flavanol metabolites(Baseline (day 0) and 14, 28, 42 and 56 days after intervention)
- Change in plasma concentration of methylxanthines(Baseline (day 0) and 14, 28, 42 and 56 days after intervention)